This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s goals and objectives as it relates to research and development.
This position is responsible for leading the scientific characterization and development of human allograft based tissue products while ensuring compliance with Aziyo’s quality and regulatory standards. The successful candidate will lead the development, optimization and qualification of a broad range of bioassays and biomechanical studies. In addition, this position will support the development of manufacturing processes to enhance productivity and product quality, including scale up for full production and /or production transfer.
Position reports to the Vice President, Research and Development
Essential Duties & Responsibilities
• Leads the design and conducts performance and characterization studies of human tissue products in accordance with industry standards.
• Supports prototype and pilot production of new products, product changes, and enhancements in coordination with Aziyo’s Manufacturing and Quality Control systems.
• Works within the product development team to ensure that products under development are optimal for manufacture and to resolve manufacturing issues.
• Develops and performs validation studies for developed tissue processes.
• Generates Standard Operating Procedures (SOPs) and technical reports.
• Maintains accurate and timely records of design and development activities in accordance with written procedures.
• Interacts with Marketing, Manufacturing, and Quality Assurance and other relevant divisions in the development of allograft products.
• Presents scientific data to various stakeholders
• Complies with Aziyo’s Quality systems
• PhD in Engineering, Life Sciences, or related field from an accredited college or university or an equivalent combination of education and work experience .
Experience and Skills
• Minimum of 4 years’ experience in biomedical, biomechanical, tissue engineering or related engineering experience required
• Minimum of 2 years’ experience within Biotech or Biopharm preferred
• Experience with bioassay (cell-based and ECM scaffold) development and validation
• Excellent written, communication, and presentation skills
• Proficient knowledge of computer programs (word processing, spreadsheets, and presentations)
• Must be able to stand for long periods of time.
Aziyo offers competitive compensation and benefits packages, which include:
Medical, Dental, Vision, Disability, Life and 401k with employer matching program.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.